Phase I and Pharmacokinetics Study to Determine the Safety of BIBX 1382 in Patients With a Solid Tumor on a Continuous Daily Oral Administration Schedule and After Single Oral and Intravenous Doses
OBJECTIVES: I. Determine the maximum tolerated dose of oral BIBX 1382 in patients with solid
tumors. II. Determine qualitative and quantitative toxicities of oral BIBX 1382 in these
patients. III. Determine predictability, duration, intensity, onset, reversibility, and dose
relationship of the toxicities of oral BIBX 1382 in these patients. IV. Determine safe and
optimal doses of oral BIBX 1382 for a Phase II study. V. Assess the pharmacokinetics of oral
BIBX 1382 in these patients. VI. Document any antitumor activity in these patients treated
with oral BIBX 1382.
OUTLINE: This is a dose escalation study. Patients receive BIBX 1382 IV over 1 hour followed
7 days later by oral BIBX 1382. Beginning 3 days later, patients receive oral BIBX 1382
daily for 28 days. Courses of daily oral BIBX 1382 repeat every 28 days in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
doses of oral BIBX 1382. The maximum tolerated dose (MTD) is defined as the dose at which
dose limiting toxicity occurs in at least 2 of 6 patients. Patients are followed for up to 4
weeks.
PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study over 18 months.
Interventional
Primary Purpose: Treatment
Christian Dittrich, MD
Study Chair
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
United States: Federal Government
EORTC-16981
NCT00003980
February 1999
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